Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab

Exclusion Criteria

• •Subject with current or prior history of statin intolerance
• •Subject has previously received Evolocumab (AMG 145) or any other investigational therapy directed against PCSK9
• •Known substance abuse (eg, alcohol, licit or illicit drugs) within 12 months of day -1
• •Testing positive for alcohol and/or drugs-of-abuse at screening, day -1, or day 1 (alcohol only)
• •History of hypersensitivity or allergic reaction to mammalian-derived drug preparations
• •Known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose